[Senate Hearing 112-175]
[From the U.S. Government Publishing Office]
S. Hrg. 112-175
RESPONDING TO THE PRESCRIPTION DRUG
EPIDEMIC: STRATEGIES FOR REDUCING ABUSE, MISUSE, DIVERSION, AND FRAUD
=======================================================================
HEARING
before the
SUBCOMMITTEE ON CRIME AND TERRORISM
of the
COMMITTEE ON THE JUDICIARY
UNITED STATES SENATE
ONE HUNDRED TWELFTH CONGRESS
FIRST SESSION
__________
MAY 24, 2011
__________
Serial No. J-112-23
__________
Printed for the use of the Committee on the Judiciary
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COMMITTEE ON THE JUDICIARY
PATRICK J. LEAHY, Vermont, Chairman
HERB KOHL, Wisconsin CHUCK GRASSLEY, Iowa
DIANNE FEINSTEIN, California ORRIN G. HATCH, Utah
CHUCK SCHUMER, New York JON KYL, Arizona
DICK DURBIN, Illinois JEFF SESSIONS, Alabama
SHELDON WHITEHOUSE, Rhode Island LINDSEY GRAHAM, South Carolina
AMY KLOBUCHAR, Minnesota JOHN CORNYN, Texas
AL FRANKEN, Minnesota MICHAEL S. LEE, Utah
CHRISTOPHER A. COONS, Delaware TOM COBURN, Oklahoma
RICHARD BLUMENTHAL, Connecticut
Bruce A. Cohen, Chief Counsel and Staff Director
Kolan Davis, Republican Chief Counsel and Staff Director
------
Subcommittee on Crime and Terrorism
SHELDON WHITEHOUSE, Rhode Island, Chairman
HERB KOHL, Wisconsin JON KYL, Arizona
DIANNE FEINSTEIN, California ORRIN G. HATCH, Utah
DICK DURBIN, Illinois JEFF SESSIONS, Alabama
AMY KLOBUCHAR, Minnesota LINDSEY GRAHAM, South Carolina
CHRISTOPHER A. COONS, Delaware
Stephen Lilley, Democratic Chief Counsel
Stephen Higgins, Republican Chief Counsel
C O N T E N T S
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STATEMENTS OF COMMITTEE MEMBERS
Page
Leahy, Hon. Patrick J., a U.S. Senator from the State of Vermont. 176
Whitehouse, Hon. Sheldon, a U.S. Senator from the State of Rhode
Island......................................................... 1
WITNESSES
Brown, Hon. Sherrod, a U.S. Senator from the State of Ohio....... 3
Eadie, John L., Director, Prescription Monitoring Program Center
of Excellence, Brandeis University, Waltham, Massaschusetts.... 18
Hosley, Laura, Manager, Community Prevention, Rhode Island
Student Assistance Services, Warwick, Rhode Island............. 16
Kerlikowske, R. Gil, Director, White House, Office of National
Drug Control Policy, Washington, DC............................ 5
Leonhart, Michele M., Administrator, Drug Enforcement
Administration, Washington, DC................................. 7
QUESTIONS AND ANSWERS
Responses of R. Gil Kerlikowske to questions submitted by Senator
Schumer........................................................ 27
Responses of Michele M. Leonhart to questions submitted by
Senator Schumer................................................ 32
SUBMISSIONS FOR THE RECORD
American Academy of Pain Medicine (AAPM), Perry G. Fine,
President, Glenview, Illinois, May 20, 2011 letter............. 36
American Pain Foundation, Scott M. Fishman, President and Chair,
Baltimore, MD, May 23, 2011, letter............................ 39
American Society of Interventional Pain Physicians (ASIPP),
Paducah, Kentucky, statement................................... 41
Casey, Hon. Robert P., Jr., a U.S. Senator from the State of
Pennsylvania, statement........................................ 112
Chaudhry, Humayun J., President and Chief Executive Officer,
Federation of State Medical Boards, statement.................. 113
Dean, General Arthur T., U.S. Army, (retired), Chairman and CEO,
Community Anti-Drug Coalitions of America, Alexandria,
Virginia, statement............................................ 118
Eadie, John L., Director, Prescription Monitoring Program Center
of Excellence, Brandeis University, Waltham, Massaschusetts,
statement...................................................... 137
Gressitt, Stevan, Founding Director, International Institute for
Pharmaceutical Safety, Portland, Maine, statement.............. 146
Hosley, Laura, Manager, Community Prevention, Rhode Island
Student Assistance Services, Warwick, Rhode Island, statement.. 159
Kerlikowske, R. Gil, Director, White House, Office of National
Drug Control Policy, Washington, DC, statement................. 169
Leonhart, Michele M., Administrator, Drug Enforcement
Administration, Washington, DC, statement...................... 177
National Community Pharmacists Association (NCPA), Alexandria,
Virginia, statement............................................ 190
Pain Care Coalition, Edward Michna, Chair, Washington, DC, May
20, 2011, letter............................................... 193
Pasierb, Steve, President and CEO, The Partnership at
Drugfree.org, New York, New York, statement.................... 201
Rockefeller, Hon. Jay, a U.S. Senator from the State of West
Virginia, statement............................................ 208
Kimberly Walsh, Deputy Commissioner, State of West Virginia,
Department of Health and Human Resources, Charleston, West
Virginia, May 24, 2011, letter................................. 210
RESPONDING TO THE PRESCRIPTION DRUG EPIDEMIC: STRATEGIES FOR REDUCING
ABUSE, MISUSE, DIVERSION, AND FRAUD
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TUESDAY, MAY 24, 2011
U.S. Senate,
Subcommittee on Crime and Terrorism,
Committee on the Judiciary,
Washington, DC.
The Committee met, pursuant to notice, at 9:04 a.m., in
room SD-226, Dirksen Senate Office Building, Hon. Sheldon
Whitehouse, Chairman of the Subcommittee, presiding.
Present: Senators Whitehouse, Klobuchar, and Blumenthal.
OPENING STATEMENT OF HON. SHELDON WHITEHOUSE, A U.S. SENATOR
FROM THE STATE OF RHODE ISLAND
Chairman Whitehouse. The hearing will come to order. This
morning's hearing considers a topic that is extremely important
to the health and safety of our kids, of our families, and of
our communities, and that is, ``Responding to the Prescription
Drug Epidemic: Strategies for Reducing Abuse, Misuse,
Diversion, and Fraud.''
Used properly, under a physician's direction, pain
relievers and other prescription drugs bring much-needed
comfort to Americans. But their abuse poses a serious and
growing threat to our communities and young people. In 2009,
approximately 7 million Americans reported misuse of
prescription drugs. The problem is particularly acute among
teenagers. Prescription drugs are the second most abused
category of drugs among our Nation's young people, and six of
the top ten abused substances among high school seniors are
prescription drugs.
Prescription drug abuse is extremely dangerous. Over the
last 5 years, emergency room visits involving improper use of
pharmaceuticals more than doubled. Too often, the consequences
were deadly. According to the CDC, drug-related poisonings are
now the leading cause of death due to unintentional injuries in
my home State of Rhode Island and in 16 other States, greater
even than motor vehicle accidents.
Diversion and abuse of prescription drugs can also impose
significant financial costs on our health care system through
emergency room visits and treatment of medical complications.
We pay for that through higher private insurance premiums and
higher Medicare and other public health costs.
The ever-growing epidemic of prescription drug abuse
demands sustained attention from law enforcement, health care
professionals, and Congress. It poses challenges similar to
those faced from other illegal drugs. As with illegal drugs,
for instance, large-scale criminal networks have developed for
the diversion and distribution of prescription drugs.
However, there are unique challenges in the prescription
drug context. These drugs can be readily available in our
homes, giving teens easy and direct access. Approximately 70
percent of people aged 12 or older who used prescription pain
relievers non-medically in 2009 got them from a friend or
relative.
Furthermore, education about the threat of prescription
drugs is more difficult because these legal drugs have an
important medical purpose, are prescribed by physicians, and
come from pharmacies. Teens are too often unaware of the
dangers of misuse and abuse.
The special characteristics of prescription drugs demand a
multi-pronged strategy for reducing wrongful use. This strategy
should include educating prescribers and patients about
responsible uses of these drugs, recognizing signs of abuse,
providing appropriate treatments and interventions, and
deploying appropriate law enforcement resources.
Electronic information-sharing systems, such as the
prescription drug monitoring programs authorized in 43 States,
are promising tools for identifying pill mills and doctor
shoppers. I was pleased to get bipartisan legislation passed
last year allowing the Government to perform sophisticated
analyses of Medicare data in order to avoid paying fraudulent
claims and to give law enforcement tools for investigating
criminal fraud. There are analogous ways to strengthen
prescription monitoring programs so that they have more
complete prescription data, use advanced analysis to identify
diversion or abuse, and better allow prescribers, law
enforcement, and others to address these problems.
E-prescribing can also play a valuable role, limiting
diversion, fraud, and medical mistakes by reducing
opportunities for forgery and error. I am pleased that Rhode
Island is a national leader in e-prescribing. We can combine
the advantages of e-prescribing and of prescription monitoring
programs to help physicians recognize early patterns of abuse.
Today's hearing seeks to advance these goals. I welcome our
witnesses from the Office of National Drug Control Policy and
the Drug Enforcement Agency, as well as from Brandeis
University and my home State of Rhode Island.
I congratulate the Obama administration on the release of
their proposals for responding to America's prescription drug
abuse crisis. I look forward to working with the
administration, Chairman Leahy, Ranking Member Kyl, and other
Senators from both sides of the aisle on legislation to protect
against prescription drug abuse.
I saw Senator Kyl this morning, and he indicated that he
may not be able to attend the hearing today. His schedule has
been, I guess, a little bit tumultuous, and if he can, of
course, I will recognize him. But if he does not, I have been
instructed to proceed.
We have Senator Sherrod Brown of Ohio here to kick off the
hearing. Senator Brown has taken a keen interest in this issue,
and we look forward to his statement. Thank you, Senator Brown.
STATEMENT OF HON. SHERROD BROWN, A U.S. SENATOR FROM THE STATE
OF OHIO
Senator Brown. Thank you, Chairman Whitehouse, for allowing
me to testify today and for your leadership on this important
Subcommittee on Crime and Terrorism.
Chairman Whitehouse and I served together on the Health,
Education, Labor, and Pension Committee where we worked closely
together on the Patient Protection and Affordable Care Act, and
throughout our time in the Senate, I valued his expertise on
the connections between our health care and our legal systems.
Today's hearing is an example of that connection, how the
rampant abuse and trafficking of prescription drugs pose both a
public health threat and a law enforcement threat. In recent
years, more Ohioans have died from prescription drug overdoses
than from car accidents. In 2008, statistics show that
oxycodone and Percocet and other prescription drugs caused more
overdoses in Ohio that year than heroin and cocaine combined.
Prescription pain medications such as OxyContin are largely
responsible for increasing overdoses and deaths in my State and
across the country. Simply put, prescription drug abuse, as the
Chairman said, is the fastest-growing drug problem in the
Nation.
Almost every day in Ohio, there is a reported story of a
child lost to prescription drug abuse or neighborhoods
harboring its illicit trade. In southeast Ohio, the most rural
part of the State, it is particularly tragic. Old factory towns
and rural communities have become havens for prescription drug
abuse. These stories, of course, are not limited to Ohio and
Rhode Island. Across the country communities are struggling to
find ways to respond and to develop strategies to reduce the
diversion and abuse of prescription drugs.
Last year, I convened a first of its kind roundtable in
southern Ohio with Federal and local law enforcement, community
activists, elected officials, drug treatment leaders, and
members from the medical community. They raised a concern with
criminal manipulation of Ohio's Medicaid program, which spends
upwards of $820 million on prescription medicines. While most
prescription pain medicines are used as prescribed, as the
Chairman pointed out, and they are valuable, some criminals
defraud the Medicaid system and fleece Ohio taxpayers by
acquiring multiple prescriptions and filling them at multiple
pharmacies.
A case of criminals defrauding taxpayers in the Medicaid
system to sell and divert prescription drugs becomes a one-two
punch in the stomach to the system. That is why last month I
introduced the Stop Trafficking of Pills Act, which would
establish a Medicaid lock-in program for Ohio and nationwide to
crack down on the use of Medicaid cards to obtain and illegally
resell prescription drugs. The bill would prevent prescription
drug abusers from acquiring excess prescription drugs which
they may abuse or illegally resell by barring them from
visiting multiple doctors and pharmacies. Nearly 20 States
already have something similar to the Medicaid lock-in program.
South Carolina's Medicaid lock-in pilot program targeted at
high-use beneficiaries spurred a 43-percent decrease in the
total number of prescribed prescription pain medications.
Consider Scioto County on the Ohio River in southern Ohio.
In this Ohio River town, prescription drugs cause nine of every
ten fatal drug overdoses. In nearly two-thirds of these cases,
the individuals involved did not have prescriptions themselves,
indicating, of course, they in all likelihood obtained the
drugs illegally. An investigation by the GAO, which audited the
Medicaid program of the five largest States, found 65,000 cases
in which Medicaid beneficiaries visited six or more doctors and
up to 46 different pharmacies to acquire these prescriptions.
This same report found approximately 800 prescriptions written
for dead patients and 1,200 prescriptions written by dead
physicians.
Under a Medicaid lock-in program, States would identify
high-risk prescription users, those who are receiving an
excessive amount of prescription drugs or those who have been
convicted of a drug-related offense. These high-risk
prescription drug users would be placed in the program and
assigned one physician and one pharmacy. It would mean no more
doctor shopping, no more pharmacy hopping.
States would identify prescription drugs that are dispensed
under Medicaid and that present a high risk of overutilization.
The legislation requires the Federal Government to set up a
similar lock-in program for Medicare, where the abuse is there
but obviously not as high. Prescription drug abuse in Ohio and
our Nation needs to be treated like the epidemic it is.
Chairman Whitehouse has been a leader on this issue, urging
the DEA to implement electronic prescribing for controlled
substances and calling for strong prescription drug monitoring
systems.
Today's witnesses will describe the administration's
comprehensive prescription drug strategy and ways FDA can crack
down on the abuse, and community activists will describe the
victims and families whom they represent, offering the stories
behind the statistics and policies being discussed.
From the policies to the stories, it is clear prescription
drug abuse knows no party lines. It is clear it is an issue of
life or death in too many parts of our Nation, at least in my
State especially in rural areas, which have experienced
terrible job loss and economic hardship for hundreds of
thousands of families.
I will stop there. I thank the Chairman for allowing me to
testify.
Chairman Whitehouse. Senator Brown, I appreciate very much
your energy and your leadership on this issue, both here in
Washington and in your home State of Ohio. It seems that Ohio
and Rhode Island have a lot in common on this issue, and I look
forward to continuing to work with you as you go forward. I
particularly appreciate that, as busy as your schedule is, you
took the time out this morning to come to this Committee, of
which you are not a member, to make sure that your voice was
heard here, and I am very grateful to you for that.
I know your schedule commands you to be elsewhere, so thank
you very much for taking the trouble.
Chairman Whitehouse. Now I will ask our first panel, Hon.
Gil Kerlikowske and Hon. Michele Leonhart, to come forward. Let
me ask you to stand and be sworn. Do you affirm that the
testimony you are about to give before the Committee will be
the truth, the whole truth, and nothing but the truth?
Mr. Kerlikowske. I do.
Ms. Leonhart. I do.
Chairman Whitehouse. Thank you. Please be seated.
Thank you both for being here. It is an impressive turnout.
And for those of you who do not know our witnesses, Gil
Kerlikowske is the Director of the White House Office of
National Drug Control Policy. Director Kerlikowske served as
the chief of police for Seattle, Washington; was Deputy
Director for the U.S. Department of Justice Office of
Community-Oriented Policing Services; was police commissioner
of Buffalo, New York; and served in the St. Petersburg,
Florida, police department. He has been elected twice to be
president of the Major Cities Chief, and he has received
numerous awards and recognition for leadership, innovation, and
community service.
He is joined by Michele Leonhart, who is Administrator of
the Drug Enforcement Administration. Confirmed in December
2010, she had been the Acting Administrator since 2007 and
Deputy Administrator since 2004. As a career DEA special agent,
Ms. Leonhart held several key positions as she moved through
the ranks of DEA, including as assistant special agent in
charge of the Los Angeles Field Division. She has received
numerous awards, including the Rank of Distinguished Executive
in 2004, and the Presidential Rank Award for Meritorious
Service in 2005 and 2000.
It is truly our privilege to have these two witnesses here,
and why don't we go across the table. We will start with Mr.
Kerlikowske. Please proceed with your statements.
STATEMENT OF HON. R. GIL KERLIKOWSKE, DIRECTOR, WHITE HOUSE
OFFICE OF NATIONAL DRUG CONTROL POLICY, WASHINGTON, DC
Mr. Kerlikowske. Chairman Whitehouse, thank you very much
for this opportunity to address the important issue of
prescription drug abuse in our country, and I am very grateful
for the Committee's attention to this topic. Prescription drug
abuse has been a major focus at ONDCP since my confirmation,
and I have directed the National Drug Control Program agencies
to address this epidemic in our country.
I have the responsibility to raise public awareness,
coordinate Federal activities, and take action on drug issues
that affect our Nation. The efforts that we have taken are
balanced. They incorporate new research and evidence-based
approaches to address drug use and its consequences.
Prescription drug abuse is the fastest-growing drug problem
in the United States. It is categorized as a public health
epidemic by the Centers for Disease Control and Prevention. The
number of individuals who for the first time consumed
prescription drugs for a non-medical purpose was similar to the
number of first-time marijuana users. We have also seen a
fourfold increase in addiction treatment admissions for
individuals primarily abusing prescription painkillers from
1997 to 2007.
Even more alarming is the fact that about 28,000 Americans
have died from unintentional drug overdoses in 2007, and
prescription drugs, particularly the opioid painkillers, are
considered major contributors to the total number of drug
deaths. And we believe there are two unique reasons for the
growth in prescription drug abuse: easy accessibility to the
drugs and the diminished perception of risk. A comprehensive
approach is required to address this epidemic. It is important
to balance prevention, education, and enforcement with the need
for legitimate access to controlled substances.
The administration has created an inclusive Prescription
Drug Abuse Prevention Plan that brings together Federal, State,
local, and tribal groups to reduce prescription drug diversion
and abuse. The plan expands upon the administration's National
Drug Control Strategy and has four major areas.
The first is education. Mandatory prescriber education as
well as patient and parent education is essential. Sixty-nine
percent of narcotic analgesics are distributed in primary care
offices and emergency departments. In addition, we want to make
sure that patients and parents are fully aware of the dangers
and the prevalence of prescription drug abuse and that they are
educated about the safe use and proper storage and disposal of
these medications. The FDA is implementing a Risk Evaluation
and Mitigation Strategy plan that requires manufacturers of
long-acting and extended-release opioids to ensure that
training is provided to prescribers.
The second part of our plan includes that each State have a
Prescription Drug Monitoring Program (PDMP), and Senator Brown
mentioned the importance of those, and I know you have another
witness that will be talking about those. But we are strongly
supportive of those and that they have interoperability and
that they be used by all of the prescribers.
We have also made significant investments in health
information technology and continue to work with HHS
particularly on health information exchanges. Opportunities
include identifying ways to incorporate real-time PDMP data at
the point of care and dispensing.
The third part of the plan calls for proper medication
disposal. Unused medications that sit in our medicine cabinets
are falling into the wrong hands, and by creating a method for
proper disposal of expired or unused prescription drugs, we
will benefit public health, public safety, and the environment.
Passage of the Secure and Responsible Drug Disposal Act in 2010
was an important step forward in our efforts to make
prescription drug disposal more accessible to individuals and
to reduce the supply of drugs available. A drug disposal
program has to be easily accessible to the public,
environmentally friendly, cost-effective, and the cost burden
should not be placed on consumers.
The last part of the plan is smart law enforcement. You
have the expert sitting to my left to talk about that, but our
main effort will be, as they have already done with the DEA's
comprehensive work on pill mills, to address the issue of
doctors who overprescribe, and of course, PDMPs help with
doctor shopping. Our office, ONDCP, supports the HIDTAs, the
High-Intensity Drug-Trafficking Areas, and we want to make sure
that local law enforcement, with the cooperation of DEA, have
the support that they need to understand these complex
investigations and do a better job of bringing drug dealers to
justice.
In closing, I want to thank all of my colleagues in the
executive branch, but particularly we could not be effective in
any of these areas without the support of Congress.
[The prepared statement of Mr. Kerlikowske appears as a
submission for the record.]
Chairman Whitehouse. Thank you, Director Kerlikowske.
Director Leonhart.
STATEMENT OF HON. MICHELE M. LEONHART, ADMINISTRATOR, DRUG
ENFORCEMENT ADMINISTRATION, WASHINGTON, DC
Ms. Leonhart. Chairman Whitehouse, Senator Klobuchar, thank
you for the opportunity to discuss the growing epidemic of
prescription drug abuse and the critical role of the Drug
Enforcement Administration in the enforcement of our Nation's
drug laws and regulations.
The diversion and abuse of pharmaceutical controlled
substances is a significant and growing problem in the United
States. Every leading indicator shows increases over relatively
short periods of time in the use and abuse of these drugs. Pain
clinics have emerged as a major source of controlled substances
for non-legitimate medical purposes. DEA and other Federal,
State, and local law enforcement agencies have developed great
working relationships and continuously coordinate efforts to
combat this emerging threat.
Federal administrative and criminal actions against a
physician with controlled substance privileges is rare.
However, such actions are warranted when a physician is issuing
controlled substance prescriptions for an illegitimate purpose
and operating outside the usual course of professional
practice. And as Administrator, I have made prescription drug
abuse a top priority.
I am especially alarmed that another contributing factor to
the increase in prescription drug abuse is the availability of
these drugs in the household. In many cases, prescription drugs
remain in household medicine cabinets well after medication
therapy has been completed, thus providing easy access to non-
medical users for abuse, accidental ingestion, or illegal
distribution for profit. And the 2010 Partnership Attitude
Tracking Study, which we call PATS, noted that 51 percent of
those surveyed believe that most teens get prescription drugs
from their own family's medicine cabinets.
DEA manages a robust regulatory program aimed at preventing
and curbing diversion, all the way from the manufacturing level
to the dispensing of these medications to patients. In working
with Congress, DEA also obtained new authority last year to
regulate the disposal of unused medications by ultimate users,
thereby getting unused medications out of the household
medicine cabinets in a lawful manner.
DEA is working diligently to promulgate disposal
regulations. In the interim, DEA launched a nationwide take-
back initiative in September of last year and again in April of
this year, resulting in the combined collection of 309 tons of
unwanted or expired medications. And DEA will continue to hold
periodic take-back events until regulations are in place.
DEA's obligation under the law and to the public is to
ensure that pharmaceutical controlled substances are prescribed
and dispensed only for legitimate medical purposes in
accordance with the Controlled Substances Act. And by carrying
out this obligation, DEA strives to minimize the diversion of
pharmaceutical controlled substances for abuse while ensuring
that such medications are fully available to patients in
accordance with the sound medical judgments of their doctors.
In this manner, DEA is committed to balancing the need for
diversion control and enforcement with the need for legitimate
access to these drugs.
DEA closely monitors the closed system through
recordkeeping requirements and mandatory reporting at all
levels of the supply chain. Due to enhancements to our
regulatory resources, controlled substance manufacturers,
distributors, importers, exporters, and narcotic treatment
programs are receiving more inspections and audits than ever
before. A key component to our enhanced investigative resources
are tactical diversion squads. These unique groups combine the
skills of special agents, diversion investigators, and task
force officers. These TDS groups, as we call them, are
dedicated solely toward investigating, disrupting, and
dismantling those individuals or organizations involved in
diversion schemes, and as of today, DEA has 37 operational TDS
groups. DEA plans to add 27 more over the next few years.
One example of the effectiveness of these tactical
diversion squads is Operation Pill Nation, which has targeted
rogue pain clinics in South Florida since February of 2010 and
culminated in a series of major takedowns this past February.
This led to 32 arrests, including 12 doctors and 5 pain clinic
owners, and DEA also immediately suspended 63 DEA registration
numbers and issued orders to show cause on 6 DEA registrations,
which resulted in the surrender of 29 DEA registration numbers.
And this caused a ripple effect throughout South Florida and
resulted in 54 more registration numbers being surrendered.
DEA recognizes that it cannot solve this problem alone, and
DEA is working with our Federal, State and local, and private
sector partners as a part of this administration's
comprehensive approach to combating prescription drug abuse.
Many States also have adopted prescription drug monitoring
programs, which are deemed to be a valuable tool in curbing
diversion. The administration supports establishment of these
programs in every State because PDMPs help cut down on
prescription fraud and doctor shopping by giving physicians and
pharmacists more complete information about a patient's
prescriptions for controlled substances.
In closing, prescription drug abuse is a dangerous threat,
and DEA is determined to be a part of the solution. And with
your support and that of our partners, I know we will continue
to make a positive difference in the lives of millions of
Americans and communities across the Nation. So I thank you for
the opportunity to appear here today, and I look forward to
answering your questions.
[The prepared statement of Ms. Leonhart appears as a
submission for the record.]
Chairman Whitehouse. Thank you, Ms. Leonhart.
Chairman Leahy could not be here today, but he has offered
a statement for the record reflecting, among other things,
observations we got, Director Kerlikowske and I, with the
Chairman at the hearing that he held up in Vermont last year
with all of us together. And without objection, I will add that
to the record of this hearing.
[The prepared statement of Chairman Leahy appears as a
submission for the record.]
Chairman Whitehouse. I have a couple of questions. I think
I will probably pass on the drug disposal questions because we
are joined by Senator Klobuchar, who was the author of the
Secure and Responsible Drug Disposal Act of 2010 that was
mentioned in the testimony. But I do want to mention on that
that I was in Rhode Island the other day at the Narragansett
Bay Commission's Bucklin Point Treatment Facility, and they are
actually seeing effects from pharmaceuticals that are discarded
down the drain out in the environment as they come through the
treatment system and go out in that case into the river and
then on down to the bay. So it is not a solution necessarily to
have people dispose of this by throwing it down the drain. We
really have to improve on that, and I suspect she will urge you
to move those regulations with some degree of dispatch.
As you know, we have had a long battle over the e-
prescribing regulations. I think that has been 3 years from
when we had the first hearing, and your predecessors at DEA sat
next to people from HHS and had completely different views of
the world, and in the same administration. And I gather that
that has all been worked through, but if you could bring me up
to date on where we are under the interim final rule in terms
of actual deployment and the ability to certify contractors and
actually have e-prescribing take place in the field.
I am assuming that you view e-prescribing as an
investigative and awareness asset in the drug diversion
problem, and in that frame, I would like you to let me know
where we stand.
Ms. Leonhart. Yes, Chairman. We do view e-prescribing as an
important tool--a tool for law enforcement, actually. We have
worked very hard, especially since last March when I signed the
interim rule, which went into effect almost a year ago. June
1st will be a year. We have been in contact with the people
that are putting together the systems. They are moving forward.
And we understand the first ones may be ready this summer for
audit and then come online and be available by the end of the
year.
We have looked at a number of the comments that came in.
The interim rule is in effect now. We believe the final rule
will be ready to go early next year, and there should be no
reason that people should not be moving forward to implement e-
prescribing, which will help in many ways to include the
diversion problem of prescription drugs, as well as help with
fraud and enhance health for patients.
Chairman Whitehouse. Is there actually e-prescribing of
controlled pharmaceuticals under the interim final rule
happening now? Or are people still waiting for the contractors
to be certified so that it can actually happen? I mean, it is
one thing to have the rule be in operation. It is another thing
to actually have something happen in the real world. And I am
not sure that this has actually hit the real world yet. Could
you let me know what the status is in terms of actual flow of
data across e-prescribing networks of controlled
pharmaceuticals?
Ms. Leonhart. Well, I can tell you it has not hit the real
world yet, but the systems are being put in place. They first
need to be audited. We understand one has announced called
``Doctor First.'' It has announced that it is DEA compliant and
is ready to move forward, and I believe it is in the auditing
stages now and has identified over 150 different customers, and
that will be the first one that we have heard of that will come
online probably by the end of the year.
Chairman Whitehouse. I am not going to remember the exact
numbers that Senator Brown used, but he described individuals
who had multiple prescriptions from multiple doctors and were
using multiple pharmacies, and that is the type of thing that
this sort of system can flag so that it does not happen,
correct?
Ms. Leonhart. That is correct--that with the prescription
drug monitoring programs, we will be able to identify people
that are doctor shopping, as you just explained.
Chairman Whitehouse. I will now recognize Senator
Klobuchar, author of the Secure and Responsible Drug Disposal
Act of 2010.
Senator Klobuchar. Thank you. You remember that name better
than I do. That is pretty good.
Thank you to both of our witnesses. Director Kerlikowske
and I worked together back when he was police chief and I was
county attorney. And then, of course, Ms. Leonhart, we have
worked together as well, and you are from Minnesota so you can
do no harm, as far as I am concerned.
[Laughter.]
Senator Klobuchar. I wanted to go through--as Senator
Whitehouse mentioned, we passed into law the Secure and
Responsible Drug Disposal Act, something that Senator Cornyn
and I authored, and got it through the House, and thank you for
your help in doing that, Director Kerlikowske. And I wanted to
find out the status of the rules. You know what this bill does,
acknowledging that prescription drugs are the No. 2 way that
kids can get addicted to drugs, the drugs sitting around in
their parents' medicine cabinets. And this allows pharmacies to
do take-back programs, more than just police departments;
clarifies some of the details; also for long-term care
facilities, which it turned out were flushing a lot of these
pills down the toilet because they did not know what they could
do legally. And I know that the regulations were included as
part of the plan released by the White House.
Can you give us an update on the drafting of the
regulations? And what are some of the key issues you will be
looking at? And what do you think the timetable will be?
Mr. Kerlikowske. Senator, since it is in the design of the
rulemaking, and the White House is not influencing the
rulemaking, I would defer and ask that maybe Administrator
Leonhart answer that question. Thank you.
Senator Klobuchar. OK. Very good. Thank you.
Ms. Leonhart. Senator, I want to thank you for your
support. I am not sure that bill would have passed without your
fine support and the support of your colleagues. It is very
important to us. I am pleased to say that we are on track and
hope to have a final rule by the end of the year or early next
year. In the meantime, we have held our second take-back just
last month, which was even more successful than the first take-
back in September.
We held a hearing, an open forum hearing, in January and
had over 100 witnesses provide comments and submit comments
that we are looking at very closely. And the good news is we
are on track to have a final rule hopefully by the end of the
year or January or February of next year.
Senator Klobuchar. OK. Very good. And are you working with
various stakeholders on the rules and getting input?
Ms. Leonhart. Absolutely. The public forum had stakeholders
from all entities, and we have a wide range of recommendations
and suggestions from them. And all options are on the table to
come up with the best final rule we can get that allows for
that safe and regular disposal.
Senator Klobuchar. Very good, because I think that we know
the take-back programs are great. They are becoming more and
more popular. But to have something that would be just
commonplace in pharmacies would be the best, and certainly
helping all these long-term care facilities would be good as
well.
I had a different kind of question, and it is about the use
of synthetic drugs, including synthetic hallucinogens. And as
you know, these drugs are not prescription medications, but I
think it is clear that the abuse of these illegal drugs and
prescription drugs are closely related. And I have a bill--
Senators Grassley and Schumer have one, on certain types of
synthetics, and I have one based on--it is called 2C-E,
something that actually killed a young man in Minnesota and
almost killed a number of others at a party. And I just
wondered if you were aware of this problem, either of you, and
if we have your support in moving forward on this legislation.
Ms. Leonhart. We are absolutely aware of the synthetics,
and especially of the young man who lost his life in Minnesota
with the use of the 2C-E compound. These are synthetics that
are the drugs of the future. Whether it is synthetic cannabis
or a synthetic stimulant or hallucinogen, young people are
attracted to that, so it concerns us.
So we support any legislation, any tools that Congress can
put forward that will help us combat that, and know that in
Minnesota as well as the other States where these synthetics
have shown up, we are working with State and local law
enforcement. We are providing technical assistance, training,
to do whatever we can to put a stop to that.
Senator Klobuchar. OK. Director Kerlikowske.
Mr. Kerlikowske. And, Senator, while the process is going
on, the legislative process, we have used the bully pulpit of
the White House to be able to bring to a lot of people's
attention the problems of the things such as bath salts,
synthetic drugs, et cetera. So that has been helpful in
alerting people to the problem, and thank you.
Senator Klobuchar. Very good. I just think the more we can
list some of these as clearly illegal, that helps you with your
education process, makes parents aware of this new phenomenon
with these drugs that I do not think anyone ever anticipated a
decade ago.
My last question along the lines of the tools for all of
you to use is that the administration's plan on prescription
drugs makes reference to the role of Congress, and if you could
touch further on the role of Congress. Can you talk about the
potential need for further legislation in the area of illegal
prescription drugs? Director Kerlikowske.
Mr. Kerlikowske. Senator, we think one of the most
important parts of the comprehensive prescription drug plan
will be in mandatory prescriber education. When we developed
President Obama's National Drug Control Strategy, his direction
to me was to make sure that the voices of people across the
country were heard, and we did that and included discussion
around prescription drugs and information.
The actual prescription drug plan is more comprehensive,
more specific, and we developed it very much in the same way--
by listening to people all over the country, particularly a
number of prescribing physicians, whether they were in
emergency departments or whether they were in a number of other
locations, for instance, pain management or primary care. And
overwhelmingly the information that was provided to me by them
was that additional information and education about addiction,
about dependence, about prescribing pain medications was
important and vitally needed. And overwhelmingly they had told
me that it should be mandatory. Although voluntary education is
certainly something that people appreciate, and I know that
these are physicians who are very overworked, mandatory
prescriber education is, in my opinion, very important.
Senator Klobuchar. All right. Thank you very much.
Thank you, Mr. Chair.
Chairman Whitehouse. And now we will turn to the
distinguished Senator from Connecticut, whose many years of
exemplary service as the Attorney General in Connecticut make
him keenly aware of this issue. Senator Blumenthal.
Senator Blumenthal. Thank you, Senator Whitehouse, and
thank you for holding this hearing, and thank you especially
for being attuned to this very, very difficult and profoundly
important topic. And I thank you both for your great work on
this issue.
I want to thank you also for the recommendation from the
White House Office of National Drug Control Policy in its plan
to combat prescription drug abuse to recommend that the
Secretary of Veterans Affairs share patient information on
controlled substance prescriptions with State prescription drug
monitoring programs, which I think is very, very important. As
you know, the VA also supports this request. And I will be
introducing legislation within the coming days as part of a
comprehensive program on veterans issues to support providing
that tool in the toolbox, so to speak.
So I wonder if you or Director Leonhart could perhaps share
with us and put on the record your views as to why this
recommendation is important.
Mr. Kerlikowske. Senator, thank you very much. I could not
have a stronger partner than General Shinseki and the VA on
this issue. I do not think there is anyone in this country that
is not supportive of our active-duty military and our returning
veterans and how they can be helped. But we also know very
correctly that self-medication, the use of prescription drugs
in both the active-duty military--it has been well documented--
and also returning veterans, is a significant problem. It is a
problem for combat readiness and force readiness. It is a
problem for local jurisdictions, particularly jurisdictions
where National Guard returns and there may not be as large a
military base or presence.
Prescription drug monitoring programs that are now in
almost every State--and not all of them active, but we are
working to help them to become more robust--are only as
effective as how they are used. And if you can go into a VA
hospital and obtain prescription drugs and then go down the
street to a private physician, and the two systems do not talk
to each other, that is dangerous for the patient. It puts the
physicians in a difficult position because they do not know
about what prescriptions are being offered to that patient by a
different physician in a different facility. And so the support
of the VA and the support of the Department of Defense on that
issue, so that one system can clarify and talk to each other,
is good for our veterans and our active-duty military. And it
is clearly a patient safety issue, and I thank you for that
support.
Senator Blumenthal. Would you have anything to add, Ms.
Leonhart?
Ms. Leonhart. I would add that it is a very serious
problem: 5.3 million Americans are abusing painkillers, and
among those 5.3 million are our veterans, especially returning
veterans. And the leadership of Director Kerlikowske bringing
the VA to the table has been significant and I think will in
the end benefit all of our efforts, especially those that will
most affect veterans. And thank you for your interest in that
topic.
Senator Blumenthal. It almost enables or encourages doctor
shopping and abuse to have these two separate systems that are
completely unlinked and simply do not communicate with each
other.
How well--and I realize this is kind of an open-ended
question, but how well are the State systems working? And do
you note wide variation in their effectiveness? If you could
give us a general assessment.
Mr. Kerlikowske. There are a number of people that have
looked at these. The CDC just recently released a report,
although the data that they used was a bit dated. I have
examined them and looked at them. There are some States--
particularly what is called the KASPER system in Kentucky,
which is very forward leaning in this area, but there are
several problems, and we have addressed those in the
prescription drug plan. One is that they should be
interoperable and talk to each other.
During our 4-day trip to eastern Kentucky and also West
Virginia, we learned that doctors would have to access multiple
systems--those in Ohio, those in West Virginia, those in
Kentucky--when it came to checking on patients and making sure
that they were not overprescribing for patients who were
seeing, in fact, other physicians. So the interoperability is
key. The fact that it should be easy, that the information
should be readily accessible and should be in as close to real
time as possible, are all important efforts.
So this is a great first step, all of the States, including
the State of Florida, passing that legislation, moving forward,
now making them more robust, making them used, and making them
interoperable, are all key components of the prescription drug
plan.
Ms. Leonhart. I would add that we have seen some promising
information coming from the States that actually share that
PDMP information with law enforcement. For instance, a recent
study showed that there were lower death rates in States that
were sharing with law enforcement, specifically in California,
Texas, and New York. So it is a promising tool. Good to see
that soon there are only two States that will be without PDMPs
or without legislation pending.
Senator Blumenthal. Thank you very much. Thank you both for
your great work in this area.
Chairman Whitehouse. Just to follow up on Senator
Blumenthal's question, have you been alerted to any desire for
Federal legislative changes to support the State initiatives in
prescription drug monitoring? As I understand it, the Medicare
and Medicaid billing information, for instance, access to that
for purposes of identifying prescription drug abuse and
diversion is being accomplished primarily at the State level.
Are they running into common problems that we should attend to?
Or is the State-based process, do you think, a successful one
in terms of something that can go forward and continue to make
progress on its own without further Federal legislation?
Mr. Kerlikowske. Senator, we have widely discussed at the
different hearings and the different visits that we have had
around the country, the issue of a national PDMP. A couple
things came into play.
One, the experts that have developed those systems say they
would be very difficult to implement because of, for instance,
just the difficulty of personal identification when it comes to
common names across an entire Nation, an entire data base. That
would be a problem.
Second, that the States design these and operate these
themselves and, therefore, they can put into place the patient
privacy, the confidentiality guidelines that they would like,
and also who has access to it. I think there are a number of
best practices, and I think as the evaluation continues on, I
am pretty hopeful that the individual States by working
together--and, of course, your next witness is certainly
another subject matter expert in this--can be very helpful. But
right now I am quite satisfied with what I am seeing at the
State level.
Chairman Whitehouse. Do you agree, Ms. Leonhart?
Ms. Leonhart. I do agree. I do believe that Congress could
help, however, in the area of interoperability. And, of course,
funding is an issue for the States moving forward with these
systems.
Chairman Whitehouse. Well, thank you both very much. This
has been--do you have any further questions, Senator
Blumenthal? Are you ready for the next panel? Should we go on?
If you would like another round, I----
Senator Blumenthal. I wanted to follow up on Senator
Whitehouse's excellent question about encouraging the
effectiveness of the drug monitoring programs, and I know that
there is some reluctance to make it more national and impose
kind of national requirements. But I wonder where you see the
resistance to increasing the interoperability, which I think is
really key. As it is in so many criminal justice information
programs, the failure to link State systems is a major barrier.
So I am wondering either now or if you want to think further
about it and respond in writing or have a conversation about
it, I would be very interested in following up on that issue.
Mr. Kerlikowske. I know that the State of Ohio and the
State of Kentucky have signed an interoperability agreement to
begin sharing information. I think that shows some promise, and
I would be happy to follow up to that question.
Senator Blumenthal. Great. Thank you very much.
Thank you, Mr. Chairman.
Chairman Whitehouse. Let me thank the witnesses. Let me
reference back to a statement that Director Kerlikowske made
about his role as the bully pulpit at the White House on some
of these issues, which is a role we obviously encourage. But I
would hope that you might also be a bit of a bully pulpit
within the White House with our friends at the Office of
Management and Budget as these relevant rulemakings proceed. It
has been astounding to me as a newly elected Senator to see the
pace at which Federal rulemaking slugs forward. And while I
think the agencies themselves are not always absolved of
responsibility, it does seem that there is a common thread that
things do seem to bog down at OMB. And if there is anything you
can do to move some of these along and get OMB to expedite to
the extent that they can, I think that would be helpful.
I cannot tell you how long it took to get through the
controlled pharmaceutical e-prescribing situation, and that was
in theory with pretty much everybody on board as to the
direction it should go. So I have become--I do not know what
you would call it, but impatient, I guess, with the pace of
Federal rulemaking. And you may be in a position to expedite it
a bit, and if you can, I would urge you to do so. But I thank
you for your dedicated efforts over many years in this area,
and you, too, Ms. Leonhart. As Attorney General Blumenthal and
I both know, you have people out in our streets and in the
streets of foreign countries every day who are resourceful and
brave, who take extraordinary risks to protect us. We have both
had the pleasure and privilege of working with DEA agents who
have been really among the finest Americans I have ever had the
chance to work with. And so, I thank you for being here on
their behalf.
The panel is excused, and we will take a 2-minute break
while the next panel assembles itself. Thank you both for your
testimony.
[Pause.]
Chairman Whitehouse. All right. If the hearing room will
come back to order, my first order of business is to add to the
record of this proceeding a number of items:
First, a letter from our colleague, Senator Casey, and then
statements from the Partnership at Drugfree.org; from the
Community Anti-Drug Coalitions of America; from the American
Pain Foundation; from the American Academy of Pain Medicine;
from the International Institute of Pharmaceutical Safety; from
the Federation of State Medical Boards; and from the American
Society of Interventional Pain Physicians. I appreciate all of
their statements, and they will be, without objection, added to
the record of these proceedings.
[The statement appears as a submission for the record.]
Chairman Whitehouse. We now have our next panel. Our two
witnesses are:
First, Laura Hosley. She is manager of community prevention
for Rhode Island Student Assistance Services. She also serves
as coordinator of the Jamestown, Rhode Island, Prevention
Coalition and oversees the North Kingstown, Rhode Island, drug-
free communities grant. She previously served as project
manager at the University of Rhode Island's Cancer Prevention
Research Center, worked as a student assistance counselor in
Rhode Island middle and high schools, and directed a group
home, serving individuals with mental illness and substance
abuse problems. She has an undergraduate degree in education
and psychology from the University of Rhode Island and a
master's in management from Lesley University.
She is joined on our panel today by John Eadie, who is the
director of the Prescription Monitoring Program Center of
Excellence at Brandeis University. He previously served as
director of the Division of Public Health Protection in the New
York State Department of Health from 1985 to 1995, where he
directed the State's pharmaceutical diversion program,
including the prescription monitoring program. He was co-
founder and president of both the Alliance of State with
Prescription Monitoring Programs and the National Association
of State Controlled Substances Authorities.
If I could ask you to stand while we administer the oath.
Do you affirm that the testimony you are about to give before
the Committee will be the truth, the whole truth, and nothing
but the truth, so help you God?
Ms. Hosley. I do.
Mr. Eadie. I do.
Chairman Whitehouse. Please be seated.
Ms. Hosley, welcome. Thank you for coming down from Rhode
Island. Please present your statement.
STATEMENT OF LAURA HOSLEY, MANAGER, COMMUNITY PREVENTION, RHODE
ISLAND STUDENT ASSISTANCE SERVICES, WARWICK, RHODE ISLAND
Ms. Hosley. Chairman Whitehouse, Senator Blumenthal, thank
you for the opportunity to testify before you today on behalf
of Rhode Island Student Assistance Services and the Jamestown
and North Kingstown Substance Abuse Prevention Coalitions. I am
pleased to provide you with our perspective on effective
strategies for reducing the abuse, misuse diversion and fraud
of prescription drugs.
Rhode Island is a small State, but we seem to show up in
the top of the national statistics when it comes to substance
abuse. In 2004, the last year the National Survey on Drug Use
and Health asked about the non-medical use of prescription
drugs, Rhode Island was tied for fifth with two other States.
In 2008, when the same survey asked about the use of pain
relievers non-medically, Rhode Island came in seventh. It did
not matter which of the five counties you looked at. They were
all similar. The last Rhode Island SurveyWorks data showed that
1 percent of high school students have tried painkillers
without a doctor's prescription.
I manage a drug-free communities grant in North Kingstown.
Prior to this, I oversaw strategic prevention framework State
incentive grants. In my 20 years of working in prevention, I
had never seen such well-organized efforts as with these
grants. After the first 3 years, we saw a drop in 30-day
alcohol use of 14 percent and a 4-percent decrease in marijuana
use among high school students. We had focused our efforts on
underage drinking.
We have cooperative relationships with multiple key
partners which make it relatively easy to work on media
campaigns, policy changes, law enforcement efforts, and more.
The national prescription drug take-back program was held on
April 30th in conjunction with the DEA. In North Kingstown, the
local police department and the State police filled five boxes.
When I received the list of how many pounds of drugs were
collected, I saw that the top eight communities were either
drug-free communities grantees or had the strategic prevention
framework grant, or both. Together they had collected over 75
percent of the 1,716 pounds of drugs. Cities and towns that
have the funding can get citizens educated and involved. They
get results.
I used to be a student assistance counselor. Student
assistance counselors are on the front lines. Unfortunately,
Federal and State funding no longer covers the cost to ensure
that minimum programs are funded, especially since the safe and
drug-free schools and communities funding was eliminated. The
Rhode Island Student Assistance Program is a key element in the
prevention infrastructure since the counselors are insiders.
Along with providing early intervention, they can also assist
with evaluation, policy, and enforcement efforts in the
schools.
Last month, I heard the story of a student who barged into
a student assistance counselor's office acting confused and
incoherent. The counselor found out that she had taken
prescription drugs that were not prescribed to her, along with
LSD, and determined that she was in a drug-induced psychosis.
The girl was taken to a hospital by ambulance where she stayed
for 3 weeks. She is now back in school but needs to take
lithium, which is usually prescribed for people with bipolar
disorder, to remain stable enough to stay in school. She is
still having crying bouts and difficulty handling stress. The
boy who gave her the drugs has been released from prison and is
allowed to attend school with an ankle monitor. Two lives
connected by prescription drug abuse resulted in both having
diminished chances for future success.
While Rhode Island is just beginning to address the complex
issues related to prescription drug abuse among teens, I
believe one of our more effective prevention mechanisms will be
the student assistance program. These highly trained counselors
are onsite where access for students is easy and confidential.
Collectively, the student assistance program, working in tandem
with community coalitions, has been successful in reducing the
use and abuse of alcohol and tobacco. I have every reason to
believe that continuing and expanding the student assistance
program, along with coalitions through the drug-free
communities program, will help communities handle the
complexity of prescription drug abuse among teens.
I have provided more comprehensive recommendations in my
written statement, but in the interest of time, I would like to
focus on the one that is the most critical. I believe that with
drug use on the rise and the elimination of the safe and drug-
free schools and communities program, the Federal Government
should focus more emphasis and funding on community and school-
based substance abuse prevention and intervention strategies
and programs by explicitly requiring that drug prevention and
intervention programming be adequately included in the
reauthorization of the Elementary and Secondary Education Act
and by fully funding the drug-free communities program.
We have the potential to reduce the abuse of prescription
drugs among youth in schools and communities throughout Rhode
Island as well as nationwide.
Thank you for the opportunity to testify. I would be happy
to answer any questions you may have.
[The prepared statement of Ms. Hosley appears as a
submission for the record.]
Chairman Whitehouse. Thank you, Ms. Hosley.
We will take Mr. Eadie's statement first, and then we can
ask questions as a panel. But I wanted to thank you for the
quality of your testimony. For those who have not read it but
have just listened to you, you gave a summary today, but your
full statement will be a part of the record, and it will be
extremely helpful.
I wanted to also mention, specifically with respect to the
recommendation that this be protected in the reauthorization of
the ESEA, Senator Brown, who was here, has a very keen interest
in all of this and has--I guess he has rotated off the HELP
Committee now. I am not on the HELP Committee. We will be doing
that bill in that Committee. And Senator Blumenthal is on that
Committee as well. So Senators who have been here today--I
guess Senator Klobuchar is not, but you have very good
representation of that Committee here by, I guess, fortuity. So
it was a good recommendation for you to make at this moment.
Mr. Eadie, please proceed.
STATEMENT OF JOHN L. EADIE, DIRECTOR, PRESCRIPTION MONITORING
PROGRAM CENTER OF EXCELLENCE, BRANDEIS UNIVERSITY, WALTHAM,
MASSACHUSETTS
Mr. Eadie. Good morning, Chairman Whitehouse and Senator
Blumenthal. Thank you for the opportunity to appear before you
on behalf of the Center of Excellence for Prescription
Monitoring Programs at Brandeis University. We thank you for
the honor of testifying on this critical matter.
The Center of Excellence seeks to help end the prescription
drug abuse epidemic without compromising pain management or the
legitimate prescribing of controlled substances. In
collaboration with the Alliance of States with Prescription
Monitoring Programs, the Center provides academically sound and
practice-relevant information, evaluation, and expertise to
prescription monitoring programs and other stakeholders. The
center is funded by a grant from the Department of Justice
Bureau of Justice Assistance.
The urgency of our work is based upon our knowledge that:
daily, 50 people in our Nation die from unintentional
prescription opioid overdoses; and, daily, 20 times that number
are admitted to hospital emergency departments for opioid
overdoses.
At the Center of Excellence, we believe that we must
improve our methods for identifying and interdicting
prescription opioid abuse in order to slow down and reverse
this epidemic's ever rising toll.
The rapid growth in States with prescription monitoring
programs--and I am delighted to say that the number is now 48
States. Five have just passed legislation in the last few
weeks, and it has been signed. And we just have the District of
Columbia and two States left--is a very hopeful accomplishment.
The majority of these States have been authorized since 2003,
when the Harold Rogers Prescription Drug Monitoring Programs
Grant funding began--a program administered by the Department
of Justice's Bureau of Justice Assistance. Through that
program, competitive grants have stimulated growth and
enhancements among the PMPs. Important additional funding has
been provided by the NASPER program until this new budget. That
program, administered by the Substance Abuse and Mental Health
Services Administration, is a formula grant program that has
been important in assisting States' prescription monitoring
programs by supporting their operations.
The continued operation of PMPs and the significant
enhancements called for to address the prescription drug abuse
epidemic appear to call for continuation and expansion of both
unique programs.
In addition to Federal funding support, we need a rapid
evolution of the prescription monitoring programs into a new
generation of even more effective systems, a new generation
whose hallmark must become proactivity. The new generation will
take advantage of technological advances and integrate them
into the fabric of PMP operations. Many characteristics of the
new generation are highlighted in the White House Office of
National Drug Control Policy's new Prescription Drug Abuse
Prevention Plan, which you have discussed previously.
In addition, interstate PMP data sharing is essential. This
must be completed in order to create a national network of
State prescription monitoring programs that are interoperable
through the Prescription Monitoring Information Exchange Hub,
known as the PMIX Hub, which BJA, the IJSI Institute, and the
Alliance of States with Prescription Monitoring Programs have
been working to establish for 6 years with support from our
center. The Hub is operational today, and several States are in
process of interconnecting.
In addition, we need to work on the following issues:
We must increase the proactive reporting to prescribers
across the Nation where PMPs analyze the data within their
databases and send it out when they identify potential problems
and let prescribers and, for that matter, pharmacists know what
is going on.
We also have other changes to make within the systems. You
have touched on some of them already.
Making data more timely. Oklahoma is pioneering such an
effort today. Starting in April, they have got point-of-sale
data going into their systems.
Making access seamless, using electronic health records as
a way of doing that.
Combining prescription monitoring programs and e-
prescribing, which you have discussed, is an important element
and a new element.
Considering with public and private third-party payers the
value of mandating prescribers to assess PMP data prior to
issuing the first controlled substance prescription and
periodically thereafter as a condition of payment.
In addition, we need to increase the requested reports and
proactive use of the data for pharmacies. We need to also
develop a verification system that PMPs would carry out to tie
to dispensing, to make sure that the requirements--for example,
if there is mandatory physician education, the prescription
monitoring program should assure that that is being
accomplished, that prescribers who are not trained are not
going to prescribe, or if they do, report effectively.
We need to also--and I cannot emphasize this enough. We
need to increase and improve the access that law enforcement
agencies have to prescription monitoring program data, both in
terms of solicited reports where they request reports and in
terms of unsolicited reports where the PMPs proactively
identify problems and send them out. The same thing is true for
health professional licensing agencies.
There are other users of PMP data who need to be involved
that are not currently involved. Just as an example, the Indian
Health Services, Veterans Administration, and Department of
Defense health care systems need to be integrated. And I know
you have talked about that already, but this system has to be
beyond that because it is not just the integration of VA and
Department of Defense. It is the access to the other
prescriptions issued for the same individuals in those systems
who may be going outside to get cash paid prescriptions, which
compounds and confounds what is going on within the VA system
or the Department of Defense, and they are blind to it at the
moment.
We need to develop an early warning system, and PMPs have
the capability of doing just that.
We need to develop greater concern for youth. Our initial
analysis identified significant concerns there.
And we need to talk about mandatory prescriber education.
It is from my perspective exactly important, and I recommend it
highly to you.
[The prepared statement of Mr. Eadie appears as a
submission for the record.]
Chairman Whitehouse. Thank you, Mr. Eadie. I appreciate it.
And thank you, Ms. Hosley.
Your work in Rhode Island must have exposed you to some
pretty well informed views about where it is that youngsters,
in particular teenagers, are getting access to these
prescription drugs. And if you could comment a little bit about
that and particularly how some of the earlier testimony about
the need to improve on the regime of disposal could help this,
because as I understand it, throwing them down the drain risks
creating environmental problems, leaving them in the cabinet
risks creating abuse or encouraging abuse, and there really is
no clear third option that most Rhode Islanders are aware of.
Ms. Hosley. Well, as I wrote in my statement of record,
students seem to know who are getting their wisdom teeth pulled
and who might have access to painkillers especially. We hear
that in schools kids have access to Adderall. So it seems to be
something where the students may share the medications that
they are prescribed, but also are getting it from medicine
cabinets, from their parents and grandparents. I think just the
fact that these prescriptions are overprescribed, they do tend
to be sitting in people's homes.
So I think that increasing awareness is huge, and when we
had the take-back program, we made sure that we publicized it
in the papers and that we put it on the list serves to go to
home to all the parents so that they were aware that there was
a way for them to get the medications to a place to properly
dispose of them.
I think the fact that they cannot just go at any time is a
little difficult. I know I missed that date and still have some
prescriptions sitting at home. But I heard that next year it
might be twice in the next year. So at least if we had some
type of mechanism in place for the disposal, that would help,
but we really do need to increase the awareness.
You know, with funding such as the drug-free communities,
we can put a multi-pronged strategy in place for whichever drug
we are focusing on, and I do not think we have really done that
yet as far as prescription drugs go. It is something we need to
do, but I think that all the communities need to do it and not
just certain ones who are able to get additional funding.
Chairman Whitehouse. We have the good fortune in Rhode
Island to have one of the largest pharmacy companies in the
country headquartered right in Woonsocket--CVS--and perhaps you
and I could work together with them once the regulations are
finally through their Federal administrative rulemaking
process, either at the end of the year or early next year, as
DEA Director Leonhart suggested, and work with them on perhaps
taking a leadership role in this area. So I look forward to
working with you on that.
Mr. Eadie, the States tend to manage these prescription
drug monitoring programs. There has been a relatively limited
Federal role other than the grantmaking role. Interoperability
has come up as an area where it might be suitable for the
Federal Government to provide some support and some guidance to
these State-based programs.
It appears that their State base actually is an asset in
terms of awareness of local conditions, comfort about privacy
and security issues, and things like that. Without taking those
elements away, without making this something other than the
State-based program that it is and has been, are there other
ways than the interoperability where you think that the Federal
Government could have a helpful role in supporting and guiding
what would remain under this model a State-driven prescription
drug monitoring program?
Mr. Eadie. Chairman Whitehouse, I think there is a role. I
think that things we--in mandatory education, for example, if
that is required, then it should be a corollary that
prescription monitoring programs should build into their system
an ability to track that and make sure that the trained
physicians are the ones who are--and dentists, for that matter,
and other prescribers, are the ones who are actually
prescribing. That is a simple thing.
Now, the larger question is how to involve the Federal
Government without disrupting the value of the State-based
systems, and the responsiveness that you have indicated is
extremely important.
Innovation is also important. Without State-run programs,
we would not have the electronic prescription systems available
to doctors today. That was an innovation that started with the
State of Nevada just a little over a dozen years ago, and it is
now widespread across the Nation. I mentioned Oklahoma as an
example. They are starting point of sale. They are pioneering
that effort.
Massachusetts is pioneering efforts today for electronic
health records integration. They also have an electronic-
prescribing system testing in western Massachusetts, which you
may or may not be aware of, but it was approved with a waiver
by the Drug Enforcement Administration. It is funded by the
Administration for Health Research and Quality. It is a small-
scale project, but it has demonstrated that electronic
prescribing by physicians can be operational and is effective,
and that is ongoing today. It is actually operational at the
moment. And we have been party to that and supporting that as
it goes forward, and I think there is a major role for the
future for that.
I think that electronic prescribing should be integrated
with PMPs. At the moment that is not possible because it does
not exist. But it should be integrated as quickly as possible,
and I think that Federal funding support, which indicates
support for that initiative, is important.
In short, I think that broad guidelines of criteria or of
guidance are valuable. Being too specific at the Federal level,
which is a tendency to anchor into Federal law or regulations
specific things that States should do, will ossify the systems
at a point today where the technology is rapidly evolving. We
cannot afford to have anything that is rigid. But there can
certainly be guidelines. There can certainly be statements of
encouragement. There can be, in effect, minimal guidance such
as States that are receiving Federal funding for PMPs should
have built into them interoperability with them and other
States. There should be or could be--the same thing as it
relates to e-prescribing and other things--broad categories of
requirements without specifics so that we can innovate, we can
create, we can go forward.
Chairman Whitehouse. OK. Well, we are certainly interested
in that in Rhode Island because, as you know, we are one of the
top e-prescribing States in the country.
Mr. Eadie. Yes.
Chairman Whitehouse. We sort of go back and forth with
Massachusetts as to who claims to be No. 1.
Mr. Eadie. Exactly.
Chairman Whitehouse. And we are advanced enough in
electronic health records that we are actually looking at a
statutory health information exchange. And as we speak, data is
actually flowing through something called Current Care in Rhode
Island so that it is being populated automatically into
electronic health records outside of a single corporation but
across entities. So we look forward to working with you on
those ideas, and I think if we can do that, then people who are
at the front lines working with kids like Ms. Hosley will have
an additional, as Senator Blumenthal said, tool in their
toolbox.
And with that, Senator Blumenthal.
Senator Blumenthal. Thank you, Mr. Chairman, and thank you
both for being here from Massachusetts and Rhode Island, and
thank you both for your work in this area. And I hope that
folks in Rhode Island know how active and aggressive Senator
Whitehouse has been with his background in law enforcement, but
also his leadership in really moving the Judiciary Committee to
take cognizance and take action in this area.
I want to ask you about some of the potential actions that
drug companies themselves could take in the area of
discouraging or stopping drug abuse, apart from improving the
monitoring programs that exist in many States, particularly
with respect to painkillers, whether there are actions that can
be taken to provide for greater safeguards in these areas.
As you well know, OxyContin has been a continuing problem,
oxycodone. There was an action by the Department of Justice and
States, including Connecticut while I was Attorney General,
relating to OxyContin. And the failure of the company that
produces it to really follow perhaps more responsible measures
in the marketing and selling of the pills that were subject to
pain release mechanisms. And I do not want to single out,
because it would be unfair to do so, any one company, but I
wonder if you could give us your observations as folks who are
dealing firsthand, on the ground, in the trenches, with this
problem about actions that you see the pharmaceutical drug
companies themselves potentially taking to reduce this problem.
Ms. Hosley. I am not sure whose responsibility it would be,
but perhaps if a shorter timeframe was given when those
prescriptions were prescribed so that they did not get a 30-day
prescription for having their wisdom teeth removed and maybe
had a 3-day with the option to renew. I think there is too much
medication out there, and I think it is way beyond what needs
to be out there, and that just invites the misuse and abuse of
the drugs.
Mr. Eadie. I would recommend great care in the way in which
funding from the manufacturers might be considered. Perhaps in
the prevention area, the substance abuse prevention area, it
would be helpful for having funding available. It certainly is
an area where they have a need to share responsibility for what
has happened with the use of their drugs.
When it comes to issues closer to regulatory activities and
things like the prescription monitoring programs, I think that
one has to be very careful about considering funding that is
perhaps voluntary or so-called voluntary. I can give the
example of our own situation at the Center of Excellence. We
were approached by a major drug manufacturer in our first month
of existence and asked if we would be willing to collect data
from prescription monitoring programs and provide it to them
for their RIMS obligation as it related to a new product they
were bringing on the market, a new controlled substance
product. And we thought about it carefully and decided that we
could not do that in good faith because, No. 1, there would be
the appearance perhaps of conflict of interest on our part to
do that; and second would be the potential reality of it--that
is, there would be no way we could look at the data without
knowing somewhere in the back of our minds that how we analyzed
the data, the way we presented it, the kinds of charts we
produced, the analysis we stated, all could be inadvertently
influenced by our knowledge that future funding would rest on
how happy that manufacturer would be with the reports we
produced.
When we said no, thanked them, they came back with a
counter proposal that we then serve in that capacity with 21
drug manufacturers, the ones working with the FDA on the RIMS
project for the class-wide RIMS for the extended-release
opioids. And we thought about that again. There was great value
in collecting the data from the States. We still want to do
that. It is very important to collect the data and analyze it.
We know that from experience. But once again, the two caveats
that I mentioned a moment ago came back to our cognitive
function as we thought about it very carefully, and we thought
about how easily a word change can be made in a document from a
word that is choice of phrase, choice of how things are
presented, there would be no way that we could protect
ourselves against the thought in the back of our minds that
next year's money would be dependent on how happy these
manufacturers are with what we produce. And so we ultimately
thanked them but said no.
Having said that, I think that applies generally across the
board to any of the prescription monitoring program activities
that States are involved with. I honor what the Florida State
Legislature has just done in passing a law that refuses to
allow their prescription monitoring program to accept funds
from drug manufacturers, either directly or indirectly. I think
that was a major step forward. As you probably know, there was
$1 million offered to them by a drug manufacturer. But let me
give you examples.
We know that there are drug manufacturers that have been
very active in supporting prescription monitoring programs for
the last decade. But if you read their materials very
carefully, there is no provision within that for the kind of
proactive analysis of data and distribution of that data that
is absolutely essential for prescription monitoring programs to
go forward, particularly as it relates to law enforcement. And
there is also--there has been in recent years a number of
States that have enacted laws that have provided restrictions
on law enforcement that extend to requiring court orders,
requiring subpoenas, requiring a variety of what amount to, in
our view, inappropriate restrictions on law enforcement's
access to the data.
And so I think that there is room for manufacturers on the
other hand to contribute to a fund that might be
Congressionally mandated like the Food and Drug Administration
establishes a fund that pays for its costs and which
manufacturers are mandated to contribute to that fund, and the
fund is then used to cover the costs of the FDA in reviewing
and approving their drugs.
Why couldn't, why shouldn't there be an equivalent fund
established by mandate of the Federal Congress to drug
manufacturers to contribute significantly to the funds
necessary to operate these prescription monitoring programs?
They benefit by it extraordinarily. There is no reason why they
cannot and should not contribute to the solution to the
problems created by their drugs.
Senator Blumenthal. Well, I thank you for that answer. My
time is up, but I look forward to working with both of you, and
I want to say that the maker of OxyContin, by the way, has
taken some very responsible steps. Purdue Pharma has taken some
very important leadership steps in reason to these problems.
And one area where I was thinking more could be done is in
providing warnings, perhaps in restricting the length or amount
of prescriptions as you have suggested, Ms. Hosley. But I look
forward to working with you, and, again, thank you, Mr.
Chairman, for your work in this area.
Chairman Whitehouse. Thank you, Senator Blumenthal.
Let me thank my colleagues Senator Brown, Senator
Klobuchar, and Senator Blumenthal all for participating in this
hearing and, I guess, wrap up by saying how impressed I think
we all have been by the information that we've heard today
about the epidemic nature of the prescription drug problem and
the rapid rate at which it is growing and affecting our
emergency rooms, affecting our families, affecting our schools,
affecting our communities. The areas that appear to need
further attention and effort include public awareness, and I
was glad that the Director of the Office of National Drug
Control Policy, Director Kerlikowske, was here to talk about
his efforts in that regard.
We appear to need to better coordinate our law enforcement
resources, although it does appear that the prescription drug
monitoring programs stand out as a growing and effective State-
based vehicle for addressing this problem, but one that could
be strengthened with further integration with electronic
prescribing, further integration with electronic health
records, some integration, beginning integration with the VA,
Department of Defense, and Indian Affairs health systems, and
improved interoperability State to State. So those seem to be
worthy goals that come out of this hearing.
The last is that we do not seem to be in a very good place
yet with respect to the disposal of unused controlled
pharmaceuticals, that throwing them down the drain creates one
set of problems, leaving them in the cabinet creates another
set of problems. And we have not really developed a robust
system for finding other ways to dispose of them, and we look
forward to working particularly with the pharmacy and
pharmaceutical industry to come up with solutions since it is
their product that ultimately is at the heart of this problem.
So I appreciate Director Kerlikowske and Director Leonhart
for taking their time and sharing with us their expertise this
morning. I appreciate very much Ms. Hosley's testimony and her
work in Rhode Island on the ground with the kids who are at the
center of our attention really today, and Mr. Eadie for your
many years of service. I think that you are sort of the father
or uncle, or whatever you would call it, of the PDMP movement,
and clearly it is one of the success stories that we want to
build on as we continue to move forward and address this
epidemic.
We will keep the record of this hearing open for an
additional 7 days, an additional week, if anybody wishes to add
anything to the record. And other than that, the hearing will
adjourn, and thank you very much for your testimony.
[Whereupon, at 10:31 a.m., the Subcommittee was adjourned.]
[Questions and answers and submissions follow.]
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